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The LifeCell Tissue Expanders are intended for use in breast reconstruction following mastectomy, treatment of underdeveloped breasts, and treatment of soft tissue deformities. The LifeCell Tissue Expanders are intended for temporary subdermal implantation and are not intended for use beyond six months.

The LifeCell Tissue Expander is composed primarily of silicone elastomers. The predicate device and the LifeCell Tissue Expander utilize the same fundamental technology:

• A silicone expansion shell with a smooth or textured surface which expands with t sequential injections of sterile saline
• An injection site, a magnetic locating system, a titanium needle guard, and suture tabs .
  The LifeCell Tissue Expander is provided sterile and its packaging consists of an inner polycarbonate thermoform tray, containing a tissue expander, sealed with Tyvek® lidstock. The sealed inner tray is placed inside a sterile barrier system which is composed of an outer polycarbonate tray that is then sealed with a Tyvek® lid. The LifeCell Tissue Expander is available in multiple styles and sizes, and each product is labeled accordingly.

The provided text describes the 510(k) summary for the LifeCell Tissue Expander, and states a substantial equivalence claim to a predicate device, rather than providing specific acceptance criteria and detailed performance data from a clinical study for this device. Therefore, a direct answer to all points of your request based solely on the provided input is not possible.

However, I can extract the information that is present and explain based on the common practices for 510(k) submissions focusing on substantial equivalence.

Here's a breakdown of what the document does provide:

1. A table of acceptance criteria and the reported device performance:

   • The document does not provide a table of acceptance criteria for clinical performance. Instead, it states: "The LifeCell Tissue Expander has undergone biocompatibility and preclinical testing including tensile strength, percent elongation, tensile set, joint strength testing, overexpansion testing, injection port testing and tissue expander injection port competency over time testing. The data demonstrates the LifeCell Tissue Expander possesses sufficient material and functional properties for the intended use."
   • It also states in the substantial equivalence section: "Performance data demonstrate that the LifeCell Tissue Expander functions equivalently to the predicate device."
   • Therefore, the primary "acceptance criterion" demonstrated is that its material and functional properties are sufficient for intent and are equivalent to the predicate device. Specific numerical acceptance criteria were likely part of the internal testing protocols, but are not disclosed in this summary.

2. Sample size used for the test set and the data provenance:

   • The document does not specify a sample size for a clinical test set. The testing described is preclinical (biocompatibility, mechanical properties) and not human clinical data. Therefore, provenance in terms of country of origin or retrospective/prospective is not applicable for this type of submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. This submission focuses on preclinical testing and substantial equivalence, not a study requiring expert readers to establish ground truth on clinical images or patient outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. This is a preclinical submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This device is a physical tissue expander, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the preclinical tests, the "ground truth" would be established by the specifications and standards for each material and functional test (e.g., a specific tensile strength value that must be met, or a specific range for percent elongation). For biocompatibility, it would be validated according to ISO standards.

8. The sample size for the training set:

   • Not applicable. This refers to a physical device submitted under the 510(k) pathway for substantial equivalence, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established:

   • Not applicable.

In summary, for the LifeCell Tissue Expander 510(k) submission, the "study that proves the device meets the acceptance criteria" is outlined as preclinical (biocompatibility, tensile strength, elongation, joint strength, overexpansion, injection port competency) testing. The acceptance criteria themselves are not explicitly detailed in the provided summary beyond the general statement that "The data demonstrates the LifeCell Tissue Expander possesses sufficient material and functional properties for the intended use" and that its "Performance data demonstrate that the LifeCell Tissue Expander functions equivalently to the predicate device."

This is typical for a 510(k) submission asserting substantial equivalence, especially for a device like a tissue expander. The FDA determined that based on this preclinical data and the comparison to the predicate, the device is substantially equivalent and thus safe and effective for its intended use. Clinical studies with human subjects are often not required for this type of device if substantial equivalence to a well-understood predicate can be demonstrated through material and functional testing.

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